Events

Retiro De Equipo (Recall) de Device Recall nordicTumorEx 1.0

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por NordicNeuroLab AS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78460
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2042-2018
  • Fecha de inicio del evento
    2014-12-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159617
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, image processing, radiological - Product Code LLZ
  • Causa
    An error was discovered in the interpretation of certain dicom header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
  • Acción
    The firm notified their consignees of the software problem by email on December 14, 2014. For further questions please call (262) 337-2909.

Device

Device Recall nordicTumorEx 1.0
  • Modelo / Serial
    Version 1.0.4
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
  • Descripción del producto
    nordicTumorEx 1.0 || nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
  • Manufacturer
    NordicNeuroLab AS

Manufacturer

NordicNeuroLab AS
  • Dirección del fabricante
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • Empresa matriz del fabricante (2017)
    Søre Øverli As
  • Source
    USFDA